NCT01011335

Brief Summary

This study involves the use of investigational vaccines. A vaccine is a medicine that causes the body to make antibodies. Antibodies help destroy foreign substances that enter the body. The purpose of this study is to find the right dose of a new vaccine that is safe and produces a good immune response (how well your body recognizes and defends itself against harmful foreign substances). There are two Staphylococcus aureus toxoids (components or antigens) under investigation in this study; one of them is a protein known as rAT and the other is a protein known as rLukS-PV. They are being developed to see if they are effective at preventing infections caused by the bacteria Staphylococcus aureus.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
6.8 years until next milestone

Results Posted

Study results publicly available

December 12, 2017

Completed
Last Updated

March 7, 2023

Status Verified

February 1, 2023

Enrollment Period

1.3 years

First QC Date

November 9, 2009

Results QC Date

June 21, 2013

Last Update Submit

February 13, 2023

Conditions

Staphylococcus Aureus

Keywords

Staphylococcus aureusSkin and soft tissue infectionMethicillin-resistant Staphylococcus aureusRecombinant alpha-toxoid (rAT)Recombinant LukS subunit of Panton-Valentine Leukocidin (rLukS-PV)

Outcome Measures

Primary Outcomes (2)

  • Assessment of Safety Through Clinical Examinations, Clinical Laboratory Results, Self-reported Diary Reactogenicity Data and Adverse Event Reports

    Adverse events, local reactogenicity, and systemic reactogenicity were assessed through clinical examination by study providers, clinical lab results, as well as review of subject-completed diary

    Up to 6 months

  • Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population

    Immunogenicity is the ability of a particular substance, such as an antigen or epitope, to provoke an immune response in the body of a human or animal. Immunogenicity was determined on the basis of anti-rAT and anti-rLukS-PV IgG concentrations assessed by enzyme-linked immunosorbent assay (ELISA) in sera from blood samples collected on Days 0 (baseline), 14, 28 and 84 for those receiving a single dose of vaccine. For those receiving a second dose of vaccine, immunogenicity assessments were also conducted on Days 98 and 112. Immunogenicity was evaluated using the following metrics: geometric mean concentrations (GMCs), geometric mean fold increase (GMFIs) and seroresponse status. Seroresponse variables are normally defined in terms of exceeding a threshold.

    Up to 3 months

Study Arms (3)

Active Vaccine

EXPERIMENTAL

Monovalent rAT or Monovalent rLukS-PV or Bivalent rLukS-PV / rAT

Biological: Monovalent rATBiological: Monovalent rLukS-PVBiological: Bivalent rLukS-PV / rAT

Placebo with Alum

PLACEBO COMPARATOR
Biological: Placebo with adjuvant

Saline Placebo

PLACEBO COMPARATOR
Biological: Placebo

Interventions

Monovalent rATBIOLOGICAL

10, 25, 50 or 100 μg

Active Vaccine
Monovalent rLukS-PVBIOLOGICAL

10, 25, 50 or 100 μg

Active Vaccine
Bivalent rLukS-PV / rATBIOLOGICAL

10, 25 or 50 μg

Active Vaccine
Placebo with adjuvantBIOLOGICAL

Placebo with adjuvant

Placebo with Alum
PlaceboBIOLOGICAL

Placebo saline

Saline Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adult males or females, DoD beneficiaries, including active duty members, 18-55 years of age.
  • Negative urine pregnancy test for female subjects of child bearing potential (negative test within 24 hours prior to investigational product injection) or documented surgical sterility.
  • Female subjects of child-bearing potential must use an acceptable method of birth control, as determined by the PI.
  • Willingness to participate in this study as evidenced by written informed consent.

You may not qualify if:

  • Prior receipt of S. aureus rAT or rLukS-PV
  • Known S. aureus infection requiring medical treatment within the 3 months prior to investigational drug product injection
  • Known active viral or bacterial infection
  • Seropositivity for HIV infection
  • Known or suspected abuse of prescribed or illicit drugs, or alcohol in the past year
  • Use of any new medications (except oral contraceptives, over-the-counter medications, or vitamin supplements) within the 7 days prior to investigational drug product injection
  • Use of investigational drugs, vaccines, or devices during the study or within the 30 days prior to each dose of investigational drug product injection, or anticipated use of such items during the study
  • Use of systemic steroids (any dose) or high daily dose inhaled steroids within the last month. Use of low or medium daily dose inhaled, intranasal, or low potency topical steroid creams/ointments is allowed unless such medication was begun within the previous 7 days.
  • History of a bleeding or coagulation disorder; or use of anti-coagulant medications within 7 days prior to investigational product injection
  • Actively breastfeeding
  • Presence of grade I or higher abnormality in laboratory or vital signs parameter at time of screening
  • Presence of any condition which, in the opinion of the investigator, places the subject at undue risk or potentially jeopardizes the quality of the data to be generated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Naval Medical Center Portsmouth

Portsmouth, Virginia, 23708, United States

Location

MeSH Terms

Conditions

Staphylococcal InfectionsSoft Tissue Infections

Interventions

Adjuvants, Pharmaceutic

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Pharmaceutic AidsPharmaceutical PreparationsSpecialty Uses of ChemicalsChemical Actions and Uses

Limitations and Caveats

Numbers in each of the dose arms were small

Results Point of Contact

Title
David Tribble, MD, DrPH
Organization
Uniformed Services University of the Health Sciences
dtribble@idcrp.org
301-816-8404

Study Officials

  • Michael L Landrum, MD

    Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences

    PRINCIPAL INVESTIGATOR

  • Paul Kessler, MD

    Nabi Biopharmaceuticals

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2009

First Posted

November 11, 2009

Study Start

November 1, 2009

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

March 7, 2023

Results First Posted

December 12, 2017

Record last verified: 2023-02

Locations

US(2)